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Observation on the Clinical Effect of Remimazolam Sulfonate Combined with Afentanil in Gastric and Colon Endoscopy under Painless Condition

Observation on the Clinical Effect of Remimazolam Sulfonate Combined with Afentanil in Gastric and Colon Endoscopy under Painless Condition

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102279
Enrollment
Unknown
Registered
2025-05-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Painless gastroscopy and colonoscopy

Interventions

The group treated with alfentanil combined with propofol (AP group):During the induction period, 7 µg/kg of alfentanil was slowly injected intravenously, and then 10 seconds after the intravenous inje

Sponsors

Jiangxi Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Patients scheduled for elective painless gastro-intestinal endoscopy; 2. Age range: 18 - 60 years old, gender not limited; 3. Body Mass Index (BMI): 18 - 29 kg/m2; 4. ASA grade I - III; 5. Participants voluntarily participated in this study and signed the informed consent form of this study.

Exclusion criteria

Exclusion criteria: 1. Those allergic to opioid drugs, benzodiazepine drugs, propofol, flumazenil or naloxone excipients; 2. Those suspected of abusing narcotic analgesics or sedatives, as well as alcoholics; 3. Those with severe arrhythmia; 4. Those with a history of acute respiratory tract infection within 2 weeks and unhealed disease; 5. Those with a history of serious heart, brain, lung, liver, kidney or metabolic diseases; 6. Those with neuromuscular system diseases (such as myasthenia gravis); 7. Those with mental disorders; 8. Those with preoperative hypertension with systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg, or hypotension with < 90/60 mmHg; 9. Those who are predicted to have or have had difficult airways, such as modified Mallampati grade III-IV; 10. Pregnant or lactating women and those with a fertility plan within 3 months (including males); 11. Other subjects that the researchers consider not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Incidence of intraoperative respiratory depression;

Secondary

MeasureTime frame
Motor function grading;Awakening time;Satisfaction rating;

Countries

China

Contacts

Public ContactMingsheng Zhang

Jiangxi Provincial People's Hospital

liyunjie0226@163.com+86 157 7072 7288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026